Federal Register notice: FDA announces that a collection of information entitled Obtaining Information to Understand and Challenges and Opportunities ...
FDA publishes a guidance with recommendations for the reporting category and the content of post-approval changes for sterile drug glass vials and sto...
The Office of Prescription Drug Promotion will study how multiple indications in consumer TV ads affect consumers recall and understanding of the indi...
A New York federal judge enters a permanent injunction against dietary supplement manufacturer Confidence USA and two of its executives.
FDA accepts for review a Regeneron Pharmaceuticals and Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on treatment for children aged 6 to ...
Taxpayers Protection Alliance senior fellow Ross Marchand says FDA needs to overcome its aversion to approving rapid home-based Covid-19 tests.
Federal Register notice: FDA issues an order to permanently debarring former Insys vice president Michael Gurry from providing services in any capacit...
Federal Register notice: FDA issues an order permanently debarring Lawrence B. Ryan from providing services in any capacity to a person that has an ap...